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Pronestyl (Procainamide Hydrochloride) - Summary

 


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WARNING

The prolonged administration of procainamide often leads to the development of a positive antinuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefits versus risks of continued procainamide therapy should be assessed.

 

PRONESTYL SUMMARY

PRONESTYL® TABLETS
Procainamide Hydrochloride Tablets USP

PRONESTYL® CAPSULES
Procainamide Hydrochloride Capsules USP

PRONESTYL (procainamide hydrochloride), a Group 1A cardiac antiarrhythmic drug, is p-amino-N-{2-(diethylamino)ethyl}-benzamide monohydrochloride, molecular weight 271.

PRONESTYL (procainamide hydrochloride) is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of PRONESTYL, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Initiation of PRONESTYL treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.

Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (See WARNINGS and Boxed WARNING.)


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PRONESTYL NEWS HIGHLIGHTS

Published Studies Related to Pronestyl (Procainamide)

Levofloxacin and ciprofloxacin decrease procainamide and N-acetylprocainamide renal clearances. [2005.04]

Emergency department use of intravenous procainamide for patients with acute atrial fibrillation or flutter. [2007.12]

Comparative study of intravenous amiodarone and procainamide in the treatment of atrial fibrillation of recent onset. [2007.08]

A comparative study of the efficacy and safety of procainamide versus propafenone versus amiodarone for the conversion of recent-onset atrial fibrillation. [2007.06.15]

Study of feasibility of the treatment with procainamide hydrochloride and cisplatin in pregnant mice. [2006.12.15]

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Clinical Trials Related to Pronestyl (Procainamide)

Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia [Recruiting]

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Not yet recruiting]

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]

Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) [Completed]

Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) [Completed]

more >>

Page last updated: 2008-01-02

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